Two-step auto-injection device

ABSTRACT

An auto-injection device for delivery of a fluid medicament is provided. The device includes an ampoule having a fluid medicament contained between first and second stoppers; a first sleeve movable along the longitudinal direction relative to the ampoule; a second sleeve at least partially surrounding the ampoule and movable along the longitudinal direction relative to the ampoule; and a needle. The first sleeve is movable along the longitudinal direction relative to the second sleeve and the ampoule between a first position and a second position. The needle is unexposed in the first position but exposed along the longitudinal direction in the second position. The second sleeve is also movable along the longitudinal direction relative to the ampoule between a first position and a second position. The needle is fluidly isolated from the medicament in the first position and is in fluid communication with the medicament in the second position.

FIELD OF THE INVENTION

The present disclosure relates generally to auto-injection devices, andmore particularly to a two-step auto-injection device and method fordelivering a fluid medicament.

BACKGROUND OF THE INVENTION

Auto-injection devices are utilized in a variety of settings, typicallyto treat medical emergencies. For example, anaphylaxis is a seriousmedical emergency that can be fatal if not treated quickly. The mostcommon causes of anaphylaxis include food allergies (e.g., nut orshellfish allergies) and insect bites or stings. Certain medications canalso cause anaphylaxis. Symptoms of anaphylaxis include an itchy rash,throat swelling, and low blood pressure. Rapid diagnosis and immediateinjection of intramuscular epinephrine is often critical to prevent afatal outcome, as muscles have larger and more blood vessels thansubcutaneous tissue and intramuscular injections usually have fasterrates of absorption than subcutaneous or intradermal injections. Deathfrom anaphylaxis occurs most often in teenagers and young adults and isdirectly related to receiving injected epinephrine too late,inaccurately (e.g., outside the muscle), or not at all. Anaphylaxis mostoften occurs unexpectedly and in the absence of a trained health careprofessional. Because exposure is unpredictable, the reaction may occurrapidly, and the patient may not be near medical help at the time ofexposure, patients who are subject to severe anaphylaxis must carryepinephrine at all times. It is also necessary that the patient be ableto self-administer the epinephrine during an anaphylactic attack in anefficient, simple manner.

Currently available auto-injection devices are generally cylindrical inshape and include a spring-activated concealed needle that, whentriggered, springs forward to simultaneously pierce the skin and delivera dose of epinephrine or other medicament. Such devices are designed forsingle dose intramuscular injection for emergency treatment ofanaphylaxis.

Recent studies indicate a number of problems with the aforementionedautomatic injection devices. These devices are bulky, difficult to use,and are considered burdensome to the user. Many patients arenoncompliant when prescribed these devices and do not carry one withthem at all times for various reasons including problems with size,shape and appearance. Further, these devices have a counter-intuitivedesign that can promote accidental misfiring of a device into the palmof the user's hand rather than into the thigh or other suitable area. Inaddition, because the dose of epinephrine is delivered at the same timethat the needle is injected below the skin in a single step, there is apossibility of injection and dispersion of the epinephrine before theneedle reaches the musculature.

Therefore, it can be appreciated that anaphylaxis remains an importantand avoidable cause of death and that currently available automaticinjection devices have a number of problems associated with their designand function. These problems can contribute to incorrect use, misuse,and not carrying the unit as prescribed (non-compliance), resulting inadverse outcomes.

As such, a need currently exists for an improved auto-injection devicefor rapid injection of a fluid medicament to the desired location.

SUMMARY OF THE INVENTION

Aspects and advantages of the invention will be set forth in part in thefollowing description, or may be obvious from the description, or may belearned through practice of the invention.

In accordance with one embodiment of the present disclosure, anauto-injection device defining a longitudinal direction is contemplated.The auto-injection device includes an ampoule, a first sleeve, a secondsleeve, and a needle. The ampoule includes a fluid medicament containedbetween a first stopper located towards a proximal end of the ampouleand a second stopper located towards a distal end of the ampoule. Thefirst sleeve is movable along the longitudinal direction relative to theampoule, while the second sleeve at least partially surrounds theampoule and is movable along the longitudinal direction relative to theampoule. Further, the first sleeve is movable along the longitudinaldirection relative to the second sleeve and the ampoule between a firstposition and a second position, wherein in the first position the needleis unexposed along the longitudinal direction and in the second positionthe needle is exposed along the longitudinal direction. In addition, thesecond sleeve is movable along the longitudinal direction relative tothe ampoule between a first position and a second position, wherein inthe first position the needle is fluidly isolated from the fluidmedicament and in the second position the needle is in fluidcommunication with the fluid medicament.

In one particular embodiment of the present disclosure, theauto-injection device can be a two-step fluid medicament deliverydevice. For instance, in a first step, the needle can pierce a surfaceof skin when the first sleeve is in the second position. Further, in asecond step, fluid medicament can be delivered intramuscularly when thesecond sleeve is in the second position.

In another embodiment of the present disclosure, an opening can belocated along a proximal end of the first sleeve, wherein the proximalend of the needle is movable through the opening when the first sleeveis moved to the second position.

In still another embodiment of the present disclosure, the needle can befixed to the second sleeve.

In yet another embodiment of the present disclosure, a biasing elementcan be contained within the ampoule towards the distal end of theampoule, wherein the biasing element (e.g., a spring or a compressedgas) exerts a biasing force on the second stopper towards the firststopper.

In an additional embodiment of the present disclosure, theauto-injection device can further include a removable safety, whereinthe removable safety prevents movement of the first sleeve from thefirst position to the second position, prevents movement of the secondsleeve from the first position to the second position, or both when notremoved.

In another embodiment of the present disclosure, the ampoule can includeglass.

In still another embodiment of the present disclosure, a plastic housingcan surround the ampoule.

In one more embodiment of the present disclosure, the first sleeve andthe second sleeve can each include a plastic.

In yet another embodiment of the present disclosure, the fluidmedicament can contain epinephrine.

In an additional embodiment of the present disclosure, theauto-injection device can have a maximum length in the longitudinaldirection of less than 150 millimeters.

In accordance with another embodiment of the present disclosure, amethod for delivering a dose of fluid medicament via an auto-injectiondevice is contemplated. The device defines a longitudinal direction andincludes an ampoule containing a fluid medicament contained between afirst stopper located towards a proximal end of the ampoule and a secondstopper located towards a distal end of the ampoule; a first sleevemovable in the longitudinal direction relative to the ampoule; a secondsleeve at least partially surrounding the ampoule and movable along thelongitudinal direction relative to the ampoule; and a needle. The methodincludes positioning the proximal end of the auto-injection deviceagainst a surface of the skin, wherein the longitudinal direction of theauto-injection device is generally perpendicular to the surface of skin;piercing the surface of skin and underlying tissue with the needle bypressing the proximal end of the auto-injection device against thesurface of skin until the first sleeve moves from a first position to asecond position in a first step; and delivering the fluid medicamentintramuscularly by pressing the proximal end of the auto-injectiondevice against the surface of skin until the second sleeve moves from afirst position to a second position in a second step.

In one particular embodiment of the present disclosure, the proximal endof the first sleeve can contact a proximal end of the second sleeve whenthe first sleeve is in the second position.

In another particular embodiment of the present disclosure, the proximalend of the second sleeve can contact the proximal end of a housingsurrounding the ampoule when the second sleeve is in the secondposition.

In yet another embodiment of the present disclosure, a proximal end ofthe first sleeve can include an opening covered with a material tomaintain sterility of the auto-injection device prior to use, whereinthe material is removed prior to positioning the proximal end of theauto-injection device against the surface of skin, or wherein thematerial is pierced by the needle by pressing the proximal end of theauto-injection device against the surface of skin until the first sleevemoves from the first position to the second position in the first step.

In still another embodiment of the present disclosure, a removablesafety can prevent the first sleeve from sliding against the secondsleeve, can prevent the second sleeve from sliding against the ampoule,or both when the safety is installed (i.e., not removed), wherein theremovable safety is removed prior to positioning the proximal end of theauto-injection device against the surface of skin.

In an additional embodiment of the present disclosure, a biasing elementcan be contained within the ampoule towards the distal end of theampoule, wherein the biasing element exerts a biasing force on thesecond stopper towards the first stopper to facilitate delivery of thefluid medicament when the second sleeve is in the second position.

In one more embodiment of the present disclosure, the fluid medicamentcan contain epinephrine.

These and other features, aspects and advantages of the presentinvention will become better understood with reference to the followingdescription and appended claims. The accompanying drawings, which areincorporated in and constitute a part of this specification, illustrateembodiments of the invention and, together with the description, serveto explain the principles of the invention.

BRIEF DESCRIPTION OF THE DRAWINGS

A full and enabling disclosure of the present invention, including thebest mode thereof to one skilled in the art, is set forth moreparticularly in the remainder of the specification, including referenceto the accompanying figures, in which:

FIG. 1 depicts a longitudinal cross-sectional view of an exemplaryauto-injection device having a first sleeve, a second sleeve, an ampoulecontaining a fluid medicament contained between a first stopper and asecond stopper, and a needle according to an exemplary embodiment of thepresent disclosure before use;

FIG. 2 depicts the auto-injection device of FIG. 1 when its first sleevehas moved from a first position to a second position;

FIG. 3 depicts the auto-injection device of FIG. 1 when its secondsleeve has moved from a first position to a second position; and

FIG. 4 depicts the auto-injection device of FIG. 1 after a biasingelement has caused movement of the second stopper towards the firststopper to deliver the fluid medicament.

Repeat use of reference characters in the present specification anddrawings is intended to represent the same or analogous features orelements of the present invention.

DETAILED DESCRIPTION OF REPRESENTATIVE EMBODIMENTS

Reference now will be made in detail to embodiments of the invention,one or more examples of which are illustrated in the drawings. Eachexample is provided by way of explanation of the invention, notlimitation of the invention. In fact, it will be apparent to thoseskilled in the art that various modifications and variations can be madein the present invention without departing from the scope or spirit ofthe invention. For instance, features illustrated or described as partof one embodiment can be used with another embodiment to yield a stillfurther embodiment. Thus, it is intended that the present inventioncovers such modifications and variations as come within the scope of theappended claims and their equivalents.

Generally speaking, the present disclosure is directed to anauto-injection device for the intramuscular delivery of a fluidmedicament and a method for delivering fluid medicament using anauto-injection device. The auto-injection device can deliver the fluidmedicament in two steps, where a surface of skin is pierced in a firststep, while the fluid medicament is delivered to the intramuscularly ina separate and subsequent second step. Such a configuration, where thefluid medicament is delivered after the needle pierces the skin and hasbeen inserted into the muscle, ensures that the fluid medicament isproperly delivered to the musculature, rather than to an area just belowthe skin's surface (e.g., intradermal or subcutaneously), which canoccur with the simultaneous needle injection and delivery of the fluidmedicament. In other words, by inserting the needle into the muscle in afirst step and delivering the fluid medicament in a second step, theauto-injection device of the present disclosure enables delivery of thefluid medicament in an accurate and effective manner.

The fluid medicament contained within the auto-injection device can beany fluid medicament that can be delivered intramuscularly. In oneparticular embodiment, such as when the auto-injection device is used totreat anaphylaxis, the fluid medicament can be epinephrine. Epinephrine,also known as 4-[(1R)-1-Hydroxy-2-(methylamino)ethyl]-1,2-benzenediol,is the active principle of the adrenal medulla and an endogenouscatecholamine which acts directly on both alpha and beta adrenergicreceptors. When used in pharmaceutical compositions, epinephrine can actas a non-selective alpha and beta adrenergic agonist and can workrapidly to improve breathing, stimulate the heart, raise dropping bloodpressure, reverse hives, and reduce swelling of the face, lips, andthroat. Uses for epinephrine include emergency treatment of allergicreactions (Type 1), including anaphylaxis, induction and maintenance ofmydriasis during intraocular surgery, treatment of bronchospasm,sensitivity reactions, cardiac arrhythmias, GI and renal hemorrhage,superficial bleeding, premature labor, hypoglycemia, and cardiogenic,hemorrhagic, and traumatic shock. Epinephrine can also be used toincrease blood flow in ACLS during CPR, as an adjunct to localanesthesia, and for radiographic uses. Although the use of theauto-injection device of the present disclosure to deliver epinephrineis described herein, it is to be understood that the auto-injectiondevice and its method of use can be utilized in conjunction with anyfluid medicament that can be delivered intramuscularly.

Referring to FIGS. 1-4, an auto-injection device according toembodiments of the present disclosure is shown prior to use and duringuse. Generally, FIG. 1 depicts a cross-sectional view of an exemplaryauto-injection device 100 prior to use, where the auto-injection device100 includes a first sleeve 101 in a first position, a second sleeve 102in a first position, an ampoule 113 containing a fluid medicament 122contained between a first stopper 114 and a second stopper 115, and aneedle 119 according to an exemplary embodiment of the presentdisclosure before use. The auto-injection device 100 defines alongitudinal direction L in which the first sleeve 101, second sleeve102, ampoule 113, and needle 119 extend, as well as a transversedirection T. The auto-injection device can include a viewing window 133through which the ampoule 113 can be observed, where the fluidmedicament 122 is visible through the viewing window 133 prior to useand the second stopper 115 is visible through the viewing window 133after use and delivery of the fluid medicament 122.

As shown in FIG. 1, the first sleeve 101 and second sleeve 102 arelocated towards a proximal end 128 of the auto-injection device 100. Thefirst sleeve 101 includes a proximal end 104, a distal end 105, an outersurface 135, and an inner surface 136. The second sleeve 102 includes aproximal end 106, a distal end 107, an outer surface 137, and an innersurface 138. The proximal end 104 of the first sleeve 101 includes anopening 132 over which a needle cover 125 (plastic film or foil) can beapplied to ensure sterility of the needle 119 prior to use, where theneedle 119 is contained within an interior space formed between theproximal end of 104 of the first sleeve and a proximal end 106 of thesecond sleeve 102 and is thus unexposed along the longitudinal directionL. As discussed in more detail below, the needle 119 is movable withrespect to the first sleeve 101 such that its proximal end 143 can passthrough the opening 132, but is fixed to the proximal end 106 of thesecond sleeve 102 between its proximal end 143 and its distal end 144,such as with an epoxy or other suitable sealant material 134. Meanwhile,the distal end 144 of the needle 119 is disposed within the firststopper 114 but does not extend past the first stopper (i.e., the needle119 is fluidly isolated from the fluid medicament 122 when the firstsleeve 101 and the second sleeve 102 are both in a first position). Inaddition, the auto-injection device 100 can include a removable safety124 that, when installed, can lock the first sleeve 101 such that it isnot movable with respect to the second sleeve 102 and can lock thesecond sleeve 102 such that it is not movable with respect to ampoule113, the housing 110 (discussed in more detail below) and/or the thirdsleeve 103 to ensure that the needle 119 does not unintentionally passthrough the opening 132. The auto-injection device 100 can also includelocks 123 located along its longitudinal direction L on the first side126 and second side 127 of the auto-injection device 100, where thelocks 123 face internally and prevent reuse of the auto-injection device100 by preventing the return of the first sleeve 101 and the secondsleeve 102 to their respective first positions after the first sleeve101 and second sleeve 102 have been moved to their second positions. Assuch, the locks 123 provide a safety measure to prevent theunintentional reuse of the auto-injection device 100.

Further, the auto-injection device 100 can also include a housing 110that surrounds the ampoule 113, as well as a third sleeve 103 that ispositioned at a distal end 129 of the auto-injection device 100. Thehousing 110 includes a proximal end 111, a distal end 112, an outersurface 139, and an inner surface 140. A portion of the needle 119passes through an opening 145 in the housing 110 so that the distal end144 of the needle 119 can be disposed within the first stopper 114. Thethird sleeve includes a proximal end 108, a distal end 109, an outersurface 141, and an inner surface 142. Female threads 121 can bedisposed on the third sleeve 103 that can interface with male threads120 disposed on the housing 110 to secure the third sleeve 103 in place.An adhesive or glue (not shown) can be used to ensure that the femalethreads 121 and male threads 120 are sufficiently engaged and to ensurethat the auto-injection device 100 cannot be unintentionallydisassembled. Further, a biasing element 116 (e.g., compression spring,a compressed gas, etc.) can be included within the ampoule 113 andpositioned between the second stopper 115 and a distal end 112 of thehousing 110, where the biasing element 116 can be in a compressed statewhen the first sleeve 101 and the second sleeve 102 are in theirrespective first positions.

In its unused state, the auto-injection device is assembled such that adistance D1 exists between the proximal end 104 of the first sleeve 101and the proximal end 106 of the second sleeve 102, a distance D2 existsbetween the proximal end 106 of the second sleeve 102 and the proximalend 111 of the housing 110, a first gap 117 extending a distance D3exists between a distal end 105 of the first sleeve 101 and a proximalend 108 of the third sleeve 103, and a second gap 118 extending adistance D4 exists between a distal end 107 of the second sleeve 102 andthe beginning of the female threaded portion 121 of the third sleeve103. Regardless of the particular dimensions of the auto-injectiondevice 100, distance D3 is greater than distance D1 and distance D4 isgreater than distance D2.

Moreover, in its assembled, unused state, the auto-injection device 100can have a maximum length L1 in the longitudinal direction L of lessthan 150 millimeters, such as less than 100 millimeters. For instance,the auto-injection device 100 can have a maximum length ranging fromabout 60 millimeters to about 100 millimeters, such as from about 70millimeters to about 95 millimeters, such as from about 80 millimetersto about 90 millimeters. Further, the auto-injection device can have amaximum height H1 in the transverse direction T ranging from about 10millimeters to about 30 millimeters, such as from about 12 millimetersto about 25 millimeters, such as from about 15 millimeters to about 20millimeters. Additionally, the first sleeve 101, second sleeve 102,third sleeve 103, and housing 110 can be formed from any suitableplastic (e.g., polycarbonate, a polyolefin such as polyethylene orpolypropylene, polystyrene, etc.), while the ampoule 113 can be formedfrom glass.

Next, FIG. 2 depicts the auto-injection device of FIG. 1 after thesafety 124 has been removed, the needle cover 125 has been pierced, andthe first sleeve 101 has moved from its first position to a secondposition so that a proximal end 143 of the needle 119 is exposed alongthe longitudinal direction L and has pierced the needle cover 125 and asurface of skin 130 and contacted muscle 131. Although the needle cover125 is shown as being pierced, it is also to be understood that, in thealternative, the needle cover 125 can be removed. To arrive at itssecond position, the proximal end 104 of the first sleeve 101 is pressedagainst the surface of skin 130 while holding the third sleeve 103 atthe distal end 129 of the auto-injection device so that the longitudinaldirection L of the auto-injection device 100 is generally perpendicularto the surface of skin 130. An inner surface 136 of the first sleeve 101is slidably engaged with an outer surface 137 of the second sleeve 102so that the first sleeve 101 is movable along the longitudinal directionL relative to the ampoule 113 until the proximal end 104 of the firstsleeve 101 contacts the proximal end 106 of the second sleeve 102 andwhereby the proximal end 143 of the needle 132 has passed through theopening 132 in the proximal end 104 of the first sleeve 101 and haspierced through the needle cover 125 and the surface of skin 130 and hasentered the muscle 131. In this regard, the distance D1 is nowessentially zero since the proximal end 104 of the first sleeve 101 andthe proximal end 106 of the second sleeve 102 are now in contact.

Additionally, as shown in FIG. 2, the first gap 117 having an originaldistance D3 now spans a distance that has been reduced by the distanceD1, such that the first gap 117 now has a distance that is equal to D3minus D1. As shown in FIG. 2, the needle 119 remains fixed to theproximal end 106 of the second sleeve 102 between its proximal end 143and its distal end 144, such as with an epoxy or other suitable sealantmaterial 134. Meanwhile, the distal end 144 of the needle 119 remainsdisposed within the first stopper 114 but does not extend past the firststopper (i.e., the needle 119 is fluidly isolated from the fluidmedicament 122 when the first sleeve 101 is in a second position and thesecond sleeve 102 is in a first position).

FIG. 3 depicts the auto-injection device of FIG. 1 after its secondsleeve 102 has moved from its first position to a second position sothat a distal end 144 of the needle 119 has pierced through the firststopper 114 so that the distal end 144 of the needle 119 is in fluidcontact with the fluid medicament 122 contained within the ampoule 113and the needle 119 is thus in fluid communication with the fluidmedicament 122. So that the second sleeve 102 can arrive at its secondposition, the proximal end 104 of the first sleeve 101 is again pressedagainst the surface of skin 130 while holding the third sleeve 103 atthe distal end 129 of the auto-injection device so that the longitudinaldirection L of the auto-injection device 100 is generally perpendicularto the surface of skin 130. Now that the proximal end 104 of the firstsleeve 101 and the proximal end 106 of the second sleeve 102 are incontact as described above in FIG. 2, an inner surface 138 of the secondsleeve 102 is slidably engaged with an outer surface 139 of the housing110 toward the proximal end 111 of the housing 110 and an outer surface137 of the second sleeve 102 is slidably engaged with inner surface 142of the third sleeve 103 towards the distal end 109 of the third sleeve103 so that the second sleeve 102 is movable along the longitudinaldirection L relative to the ampoule until the proximal end 106 of thesecond sleeve 102 contacts the proximal end 111 of the housing 110. Inaddition, as the proximal end 106 of the second sleeve 102 contacts theproximal end 111 of the housing 110, the distal end 144 of the needle132 passes through the first stopper 114 so that the distal end 144 ofthe needle is now in fluid communication with the fluid medicament 122.In this regard, the distance D2 is now zero since the proximal end 106of the second sleeve 102 and the proximal end 111 of the housing 110 arenow in contact.

Referring still to FIG. 3, the second gap 118 having an originaldistance D4 now spans a distance that has been reduced by the distanceD2, such that the second gap 118 now has a distance that is equal to D4minus D2. Meanwhile, the first gap 117 having an original distance D3now spans a distance that has been further reduced by the distance D2,such that the first gap 117 now has a distance that is equal to D3 minusD1 minus D2. As shown in FIG. 3, the needle 119 still remains fixed tothe proximal end 106 of the second sleeve 102 between its proximal end143 and its distal end 144, such as with an epoxy or other suitablesealant material 134. Meanwhile, the distal end 144 of the needle 119passes through the first stopper 114 and extends past the first stopper(i.e., the needle 119 is in fluid contact with the fluid medicament 122when the first sleeve 101 is in its second position and the secondsleeve 102 is also in a second position), whereby the fluid medicament122 can now pass from the ampoule 113, through the distal end 144 of theneedle 119, and out of the proximal end 143 of the needle 119 into themuscle 131.

In addition, FIG. 4 depicts the auto-injection device of FIG. 1 afterthe biasing force of the biasing element 116 has caused movement of thesecond stopper 115 towards the first stopper 114 to facilitate deliveryof the fluid medicament 122 into the muscle 130. Referring to FIGS. 1-3,the biasing element 116 (e.g., a spring, compressed gas, etc.) isinitially in a compressed state. However, as shown in FIG. 4, as thedistal end 144 of the needle 119 contacts the fluid medicament 122contained within the ampoule 113, the biasing element 116 expands in thelongitudinal direction L to facilitate the delivery of the fluidmedicament 122 to the muscle 131, whereby the second stopper 115 movestowards the first stopper 114 and the proximal end 128 of theauto-injection device 100. As the fluid medicament 122 is delivered, thesecond stopper 115 becomes visible in the viewing window 133, whichindicates to the user that the fluid medicament 122 has been properlydelivered. Although not shown, the second stopper 115 is moveabletowards the first stopper 114 until it reaches the distal end 144 of theneedle 119 to ensure delivery of a full dose of the fluid medicament122.

As described above, the present disclosure contemplates anauto-injection device having a needle that pierces a surface of skin andis inserted into the muscle in a first step and that delivers fluidmedicament intramuscularly in a second step. Such a two-stepauto-injection device, where the fluid medicament is delivered after theneedle pierces the skin and has been inserted into the muscle, ensuresthat the fluid medicament is properly delivered to the musculature,rather than to an area just below the skin's surface (e.g., intradermalor subcutaneously), which can occur with the simultaneous needleinjection and delivery of the fluid medicament. In other words, byinserting the needle into the muscle in a first step and delivering thefluid medicament in a second step, the auto-injection device of thepresent disclosure enables delivery of the fluid medicament in anaccurate and effective manner.

This written description uses examples to disclose the invention,including the best mode, and also to enable any person skilled in theart to practice the invention, including making and using any devices orsystems and performing any incorporated methods. The patentable scope ofthe invention is defined by the claims, and may include other examplesthat occur to those skilled in the art. Such other examples are intendedto be within the scope of the claims if they include structural elementsthat do not differ from the literal language of the claims, or if theyinclude equivalent structural elements with insubstantial differencesfrom the literal languages of the claims.

What is claimed is:
 1. An auto-injection device defining a longitudinaldirection, the auto-injection device comprising: an ampoule, the ampoulecomprising a fluid medicament contained between a first stopper locatedtowards a proximal end of the ampoule and a second stopper locatedtowards a distal end of the ampoule, wherein the ampoule is completelycontained within a housing during use of the auto-injection device; afirst sleeve movable along the longitudinal direction relative to theampoule; a second sleeve at least partially surrounding the ampoule andmovable along the longitudinal direction relative to the ampoule,wherein the second sleeve is movable from a proximal end of theauto-injection device towards a distal end of the auto-injection device;and a needle located at the proximal end of the auto-injection device,wherein the needle is fixed to the second sleeve; wherein the firstsleeve is movable along the longitudinal direction relative to thesecond sleeve and the ampoule between a first position and a secondposition, wherein in the first position the needle is unexposed alongthe longitudinal direction and in the second position the needle isexposed along the longitudinal direction, and wherein the second sleeveis movable along the longitudinal direction relative to the ampoulebetween a first position and a second position, wherein in the firstposition the needle is fluidly isolated from the fluid medicament and inthe second position the needle is in fluid communication with the fluidmedicament.
 2. The auto-injection device of claim 1, wherein theauto-injection device is a two-step fluid medicament delivery device,wherein the needle pierces a surface of skin in a first step and thefluid medicament is delivered in a subsequent second step.
 3. Theauto-injection device of claim 2, wherein, in the first step, the needlepierces the surface of skin when the first sleeve is in the secondposition.
 4. The auto-injection device of claim 3, wherein an opening islocated along a proximal end of the first sleeve, wherein the proximalend of the needle is movable through the opening when the first sleeveis moved to the second position.
 5. The auto-injection device of claim2, wherein, in the second step, fluid medicament is deliveredintramuscularly when the second sleeve is in the second position.
 6. Theauto-injection device of claim 1, wherein a biasing element is containedwithin the ampoule towards the distal end of the ampoule, wherein thebiasing element exerts a biasing force on the second stopper towards thefirst stopper.
 7. The auto-injection device of claim 1, furthercomprising a removable safety, wherein the removable safety preventsmovement of the first sleeve from the first position to the secondposition, prevents movement of the second sleeve from the first positionto the second position, or both when not removed.
 8. The auto-injectiondevice of claim 1, wherein the ampoule comprises glass.
 9. Theauto-injection device of claim 1, wherein the housing comprises aplastic.
 10. The auto-injection device of claim 1, wherein the firstsleeve and the second sleeve each comprise a plastic.
 11. Theauto-injection device of claim 1, wherein the fluid medicament containsepinephrine.
 12. The auto-injection device of claim 1, wherein theauto-injection device has a length in the longitudinal direction of lessthan 150 millimeters.
 13. A two-step method for delivering a dose offluid medicament via an auto-injection device, wherein theauto-injection device defines a longitudinal direction and comprises anampoule containing a fluid medicament contained between a first stopperlocated towards a proximal end of the ampoule and a second stopperlocated towards a distal end of the ampoule, wherein the ampoule isalways completely contained within a housing during use of theauto-injection device; a first sleeve movable in the longitudinaldirection relative to the ampoule; a second sleeve at least partiallysurrounding the ampoule and movable along the longitudinal directionrelative to the ampoule, wherein the second sleeve is movable from aproximal end of the auto-injection device towards a distal end of theauto-injection device; and a needle located at the proximal end of theauto-injection device, wherein the needle is fixed to the second sleeve;the method comprising: positioning the proximal end of theauto-injection device against a surface of skin, wherein thelongitudinal direction of the auto-injection device is generallyperpendicular to the surface of skin; piercing the surface of skin andunderlying tissue with the needle by pressing the proximal end of theauto-injection device against the surface of skin until the first sleevemoves from a first position to a second position in a first step; anddelivering the fluid medicament intramuscularly by pressing the proximalend of the auto-injection device against the surface of skin until thesecond sleeve moves from a first position to a second position in asecond step.
 14. The method of claim 13, wherein the proximal end of thefirst sleeve contacts a proximal end of the second sleeve when the firstsleeve is in the second position.
 15. The method of claim 13, whereinthe proximal end of the second sleeve contacts the proximal end of ahousing surrounding the ampoule when the second sleeve is in the secondposition.
 16. The method of claim 13, wherein a proximal end of thefirst sleeve includes an opening covered with a material to maintainsterility of the auto-injection device prior to use, wherein thematerial is removed prior to positioning the proximal end of theauto-injection device against the surface of skin, or wherein thematerial is pierced by the needle by pressing the proximal end of theauto-injection device against the surface of skin until the first sleevemoves from the first position to the second position in the first step.17. The method of claim 13, wherein a removable safety prevents thefirst sleeve from sliding against the second sleeve, prevents the secondsleeve from sliding against the ampoule, or both, wherein the removablesafety is removed prior to positioning the proximal end of theauto-injection device against the surface of skin.
 18. The method ofclaim 13, wherein a biasing element is contained within the ampouletowards the distal end of the ampoule, wherein the biasing elementexerts a biasing force on the second stopper towards the first stopperto facilitate delivery of the fluid medicament when the second sleeve isin the second position.
 19. The method of claim 13, wherein the fluidmedicament contains epinephrine.